www.ema.europa.eu Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.The CHMP adopted a positive opinion for Agamree* (vamorolone), for the treatment of Duchenne muscular dystrophy, a...

www.ema.europa.eu The Committee adopted by consensus a positive opinion for a marketing authorisation Nobivac LoVo L4 (a duplicate of Nobivac L4), from Intervet International B.V., a vaccine for the active immunisation of of dogs against Leptospira interrogans serogroup Canicola serovar...

www.ema.europa.eu EMA’s Management Board met on 5 October in Amsterdam.Clinical trials in the EUThe Board adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The revision focuses on the...

www.ema.europa.eu New safety information for Omega-3-acid ethyl estersThe PRAC agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product information for medicines containing omega-3-acid ethyl esters. These medicines are indicated...

www.ema.europa.eu Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology Assessment. EUnetHTA 21 ceases to...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma (a cancer of the bone marrow). Blenrep is given to adults who have received at least...